We are looking for an experienced QA/RA manager to lead and manage the field of quality and regulation in the company. 
We are based in Hod Hasharon, Israel. 
Management of the company's quality and regulation system.
Managing and providing regulatory guidance.
Responsibility for the registration and licensing activities of the company.
Preparations of files, changes, updates.
Handling internal and external assessments.
Working with diverse regulatory authorities in different countries.

Maintains up to date knowledge, ensures adherence and compliance with local regulatory requirements and associated documents
Ensures all start up information & requirements are kept up to date in a central repository for project teams
Registration of Company studies, conducted in Israel, in the Israeli Ministry of health (MoH) mytrial website
Works in close collaboration with the study Clinical Project Manager (CPM) and the assigned Regulatory representative for the study, provides status updates on an ongoing basis, escalates when required
May assist with the translation and co-ordination of translations for documents required for submission
Contributes to the study start-up activities including local adaptation of study master ICF(s)
May be delegated to act as the primary contact with investigative sites during site start-up activities
May support in the collection and distribution of documents from / to sites
Ensures all essential documents are reviewed in accordance to local regulations and SOP
Prepares Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents
Responsible to prepare and submit EC and MoH (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval
Tracks metrics and study start-up timelines to identify trends and opportunities for improvement
Interacts with multiple cross-functional teams to facilitate and assist in obtaining and compiling response letters to the ECs or MoH
Tracks and prepares for submission, throughout study duration, on an ongoing basis per local regulatory requirements
Participates and provides status updates during weekly study team meetings
Collaborate with TMF on regulatory submitted docs
Identifies, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment estimation or strategy and study non-compliance
Keeps up to date with evolving regulation in collaboration with Regulatory and Legal
May actively support MoH inspection and pre-inspection activities
May support audit preparation & Corrective Action and Preventative Action (CAPA) preparation for local related issues.

Support, prepare and coordinate regulatory submissions of multi disciplinary medical devices, including electromechanical parts, software and cloud.
Develop regulatory strategy for submissions of new products and changes to existing products in compliance with 21 CFR Part 820, MDR and other markets regulations.
Prepare and maintain technical files and general safety and performance requirements.
Coordinate and communicate activities with external consultants and regulatory bodies.
Review DHF documentation to assure compliance with regulatory requirements.
Review and interpret regulatory requirements during product development and communicate to the project team.
Review of V&V protocols and reports to assure comprehensiveness, accuracy and clarity for regulatory submissions.
Support Risk Management activities.
Create, update and maintain standards list.
Support manufacturing activities.
Provide requirements for review and approve product labelling.
Support compliant handling.

Support, prepare and coordinate regulatory submissions of multi disciplinary medical devices, including electromechanical parts, software and cloud.
Develop regulatory strategy for submissions of new products and changes to existing products in compliance with 21 CFR Part 820, MDR and other markets regulations.
Prepare and maintain technical files and general safety and performance requirements.
Coordinate and communicate activities with external consultants and regulatory bodies.
Review DHF documentation to assure compliance with regulatory requirements.
Review and interpret regulatory requirements during product development and communicate to the project team.
Review of V&V protocols and reports to assure comprehensiveness, accuracy and clarity for regulatory submissions.
Support Risk Management activities.
Create, update and maintain standards list.
Support manufacturing activities.
Provide requirements for review and approve product labelling.
Support compliant handling.

Prepare and control submissions of technical documentation (e.g. clinical study reports, labelling materials) submitted to regulatory authorities, and ensure they are up-to date
Maintain contact with regulatory authorities, distributors and local partners to ensure the company remains compliant with regulatory and quality requirements
Advise the company, and in particular the R D, Product, Operations and Quality teams, on applicable standards and regulations
Conduct research and analysis of regulatory requirements and policies for new markets the company is looking to enter with existing and future products and monitor regulatory developments and changes to ensure continued conformity with regulatory requirements.
Maintain existing regulatory registration files and ensure applicable regulatory requirements

Build Regulatory strategy
Lead FDA and MDD / MDR regulatory submissions of class III medical devices
Responsible for establishment, maintenance and management of the company's Quality Management System
Support the R D team in design control processes related to DHF such as: Verification and Validation testing, risk management and engineering change control
Responsible for the development and maintenance of the DMR and DHR
Develop and review design documents
Lead company compliance audits

* Working closely with the regulatory and clinical team to implement regulatory strategies and secure excellence, and compliance to the new MDR 2017/745
* Full knowledge of Alma systems and accessories and how they meet their intended use and indications including available clinical evidence to support.
* Extended Knowledge of clinical standards and regulations.
* Writing and/or updating CEP&CERs, OMs, PMCF plans and PMCF reports, PSUR to be shared with NB (including biostatistics expertise for sample size determination and trends analysis and rationales)
* Supporting risk analysis process for existing and new projects
* Working with Contract Research Organizations to assist with the regulatory and clinical writing – including control of their work and deliverable a setting appropriate expectation to maintain compliance to required standards and regulation.
* Gathering and analyzing regulatory, marketing, R&D, service, sales information to properly update the PMCF database
* Scientific writing
* Review product promotional materials, labeling for compliance with applicable regulations and policies
* Perform gap analysis on updated or new applicable clinical laws, guidelines, standards, and guidance
* Participate in product development meetings, as required, to ensure the product follows all internal and external worldwide clinical regulatory requirements.
* Handling clinical& regulatory aspects of adverse events and vigilance
* Participating on deficiency letters and report to NB

* MDR RA team leader will be responsible for the regulatory strategy preparation, validation, and implementation.
* MDR RA team leader will take part in the development, implementation, and maintenance of product technical documentation.
* RA Support in Audit.
* Key for Alma full transition to the MDR.
* Support of R&D Projects and other departmental tasks.
* Product Family Owner in Regulatory department regarding all regulatory aspects and related tasks.
* AE management responsibility.
* Compose, review, and summarize product technical data, including verification and validation protocols and reports, that are required by regulatory agencies to demonstrate compliance with global regulations and standards.
* Experience with RMF documents, PMS/PMCF/PSUR, CER requirements, and other Verifications and validations.
* MDR 2017/745 excellent knowledge and experience with submissions. 510K submission experience- an advantage.
* Work and communicate closely with project team members to assist in obtaining regulatory approvals for the companys products.
* Assist in maintaining up to date regulatory affairs files.
* Prepare and support international submissions of the product owned.
* Participate in product development meetings, as required, to ensure the product is in compliance with all internal and external worldwide regulatory requirements.

Nayax is looking for an RF Regulatory Compliance Manager to join the hardware group. The Compliance Manager has a key role in driving the company’s hardware products through their formal Regulatory certifications. This, while leading dedicated projects combining internal teams, worldwide customers/partners and well-known external testing labs. As an RF Regulatory Compliance Manager you will:
* Have Full responsibility to certify Nayax products throughout the world (Safety, EMC, Cellular, Hazard Materials etc') – From content definition to final reports.
* Determine the relevant compliance standards and regulatory requirements for Nayax products.
* Work with suppliers & internal teams for ensuring that the designs will meet all compliance requirements.
* Hands-on execution of internal pre-tests using relevant test equipment and LabVIEW automation.
* Plan, coordinate, and manage testing at third-party labs according to known industry standards and country-specific requirements.
* Support external certifications efforts involving Nayax products including debug and failure analysis efforts.
* Keep abreast of future changes to compliance/regulatory requirements and adjust the certification plan accordingly.
* Partner with external agencies and government regulatory authorities to influence policies and requirements to support our product roadmap.

Who we are:
Nayax is a global Fin-tech company and is the leading provider for cashless payment solutions for devices such as vending machines, self-check-out stations, electric vehicle chargers and more. Nayax develops both hardware and software products, telemetry, remote management, BI solutions, and mobile apps. Nayax devices can be found all over the world, with branches in 9 countries, and 40 distributing partners. Our devices serve consumers in 55 countries and accept 26 currencies. Our HQ is in the new Herzliya Hills neighborhood. We invite you to check out our incredible offices by clicking here Join us in our fast paced, cutting edge environment. We love friendly, creative, and fun people. Nayax is constantly growing, and we are always on the lookout for enthusiastic, innovative and eager individuals to join us in our growth!